Prehospital Analgesia in Adults Using Inhaled Methoxyflurane Study (NCT06392087) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane Study
1,800 participantsStarted 2024-08-01
Plain-language summary
This study is about a new pain relief medication called methoxyflurane. Pain from injuries, like broken bones, is a big reason people call ambulances. It's important to treat pain well because it can make people sick and slow down healing. But often, pain isn't treated enough, which can lead to more problems.
Paramedics use different drugs to manage pain, but some are hard to give and need special training and equipment. Methoxyflurane is a new option. It's a gas you breathe in through a special inhaler. It's been used in Australia and New Zealand for a long time and has shown to work quickly and safely for different kinds of pain.
This study wants to see if methoxyflurane works well for people with moderate to severe pain from injuries compared to other medicines like Advil, Tylenol and opioids. It's testing if methoxyflurane can give fast pain relief and if paramedics find it easy to use. The study will help understand if methoxyflurane could be a good option for treating pain in ambulances.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Indications for analgesia therapy:
* Patients ≥ 18 years of age (using a waiver of consent process)
* Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS)
* traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention)
* Unaltered (Glasgow Coma Scale (GCS) ≥ 14)
* Normotensive (systolic blood pressure ≥100)
* Treated and transported
Patients will be given methoxyflurane as soon as the treating paramedic has determined they meet inclusion criteria.
Paramedics will follow the Advanced Life Support Patient Care Standards21 for all other care the patient requires (including pain directive if methoxyflurane does not control pain after 10 min).
Contraindications listed in the ALS-PCS will be used by paramedics in providing analgesia. Within the standards paramedics are required to record vital signs every 5 minutes including verbal NPRS.
Exclusion Criteria:
Patients with the following characteristics will be excluded (based on the Health Canada Product Monograph):
* History or family history of malignant hyperthermia
* Age \<18 years of age
* Pregnancy or breast-feeding
* Inclusion in another study not allowing the co-enrollment
* Known renal impairment
* Known liver disease
* History of use of methoxyflurane in the last 3 months
* Allergy to methoxyflurane
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.